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Clinical Trial · NCT05555017
Tracer-Guided Surgery for Recurrent Prostate Cancer
Overview
ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
Sponsor
The Netherlands Cancer Institute
Phase
Phase 2
Contacts
Pim van Leeuwen, MD, PhD (CONTACT)
pj.v.leeuwen@nki.nl
003125129111
Lotte Zuur, MD (CONTACT)
l.zuur@nki.nl
003125129111
ClinicalTrials.gov
NCT05555017Drug / Compound
PSMA-I&S
Isotope(s):
TECHNETIUM-99m
Radioisotope: Tc-99m
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 6 Hours
Decay Mode: GAMMA
Energy: 140 keV (89.1%)
Range: N/A
Decay Daughters: Tc99
Status: FDA Approval: First in 1980’s
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: MAS3
Eligibility
Inclusion
- World Health Organisation (WHO) performance status 0, 1, or 2.
- ≤ 2 lymph node metastases or local residual disease within the pelvis with sufficient PSMA expression (≥2 times regional vascular activity level) as determined by PSMA-based PET
- Charlson Comorbidity Index ≤ 4
- Had a PSMA PET/CT within 90 days before surgery
- Suitable for salvage surgery, as per institutional guidelines.
- Hormone-sensitive recurrent prostate cancer after radical prostatectomy, external beam radiotherapy or brachytherapy
- PSA-value \< 4 ng/mL in case of a local recurrence and PSA \< 3 ng/ml in case of (a) nodal recurrence(s)
Exclusion
- More than 2 lymph node metastases on PSMA PET/CT
- Castration resistance defined by clinical or biochemical progression despite a combined androgen blockade
- Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
- Non-regional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
- Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
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